Lubricant sensitivity in function of paddle movement in the forced feeder of a high-speed tablet press

Context: The negative impact of magnesium stearate (MgSt) on the hardness of tablets is a well-known phenomenon, but the influence of paddle movement in the forced feeder on the lubricant effect during tablet compression is often neglected. Objective: The purpose of this research was to investigate the influence of paddle speed in the forced feeder on tablet tensile strength (TS).Materials and methods: Mixtures of microcrystalline cellulose (MCC) and MgSt (0.5%) were blended using different methods (low & high shear). After blending, the formulations were compressed into tablets. All parameters of the tableting cycle were kept constant except the speed of the paddles in the forced feeder. Results and discussion: The blending technique affected the sensitivity of the formulation to the paddle speed. The TS of pure MCC tablets did not change in function of paddle speed, while tablets prepared by low shear mixing became softer at higher paddle speed. The TS of tablets manufactured using the high-shear mixed blend was low and did not vary in function of paddle speed, suggesting that overlubrication already occurred during the initial blending step. Furthermore, analysis of the machine parameters allowed evaluation of the influence of the paddles on the flowability, initial packing, and compactability of the powder mixtures. Conclusion: The results elucidated that during manufacturing of tablets using MgSt-containing blends care should not only be taken during the blending step prior to tableting, but also during the tableting process itself, as paddle speed can affect tablet TS, a critical quality attribute

Reduction of tablet weight variability by optimizing paddle speed in the forced feeder of a high-speed rotary tablet press

Context: Tableting is a complex process due to the large number of process parameters that can be varied. Knowledge and understanding of the influence of these parameters on the final product quality is of great importance for the industry, allowing economic efficiency and parametric release. Objective: The aim of this study was to investigate the influence of paddle speeds and fill depth at different tableting speeds on the weight and weight variability of tablets. Materials and methods: Two excipients possessing different flow behavior, microcrystalline cellulose (MCC) and dibasic calcium phosphate dihydrate (DCP), were selected as model powders. Tablets were manufactured via a high-speed rotary tablet press using design of experiments (DoE). During each experiment also the volume of powder in the forced feeder was measured. Results and discussion: Analysis of the DoE revealed that paddle speeds are of minor importance for tablet weight but significantly affect volume of powder inside the feeder in case of powders with excellent flowability (DCP). The opposite effect of paddle speed was observed for fairly flowing powders (MCC). Tableting speed played a role in weight and weight variability, whereas changing fill depth exclusively influenced tablet weight. Conclusion: The DoE approach allowed predicting the optimum combination of process parameters leading to minimum tablet weight variability. Monte Carlo simulations allowed assessing the probability to exceed the acceptable response limits if factor settings were varied around their optimum. This multi-dimensional combination and interaction of input variables leading to response criteria with acceptable probability reflected the design space

Process monitoring and visualization solutions for hot-melt extrusion : a review

Objectives: Hot-melt extrusion (HME) is applied as a continuous pharmaceutical manufacturing process for the production of a variety of dosage forms and formulations. To ensure the continuity of this process, the quality of the extrudates must be assessed continuously during manufacturing. The objective of this review is to provide an overview and evaluation of the available process analytical techniques which can be applied in hot-melt extrusion. Key Findings: Pharmaceutical extruders are equipped with traditional (univariate) process monitoring tools, observing barrel and die temperatures, throughput, screw speed, torque, drive amperage, melt pressure and melt temperature. The relevance of several spectroscopic process analytical techniques for monitoring and control of pharmaceutical HME has been explored recently. Nevertheless, many other sensors visualizing HME and measuring diverse critical product and process parameters with potential use in pharmaceutical extrusion are available, and were thoroughly studied in polymer extrusion. The implementation of process analytical tools in HME serves two purposes: (1) improving process understanding by monitoring and visualizing the material behaviour and (2) monitoring and analysing critical product and process parameters for process control, allowing to maintain a desired process state and guaranteeing the quality of the end product. Summary: This review is the first to provide an evaluation of the process analytical tools applied for pharmaceutical HME monitoring and control, and discusses techniques that have been used in polymer extrusion having potential for monitoring and control of pharmaceutical HME

Peta Kemampuan Keuangan Daerah pada Pemerintahan Kota dan Kabupaten Se-Jawa dan Bali Tahun 2004-2008: Metode Kuadran

Regional autonomy is aimed at bringing the region\u27s independence in /in!1cing the region\u27s expenditures. In its implementation, regional autonomy is still not able to realize the region\u27s independence because each region has different characteristics so that it\u27s required- a different policy. This study, aims to yap the regions Finance by independent and potential-regions, independent and less potential regions, non-independent and potential regions, and non_ independent and less potential region. Independent variables used are the growth ratio and the share ratio which is calculated using the District Revenue (PAD), Tax sharing (BHP), Non-Tax sharing (BHBP) and Total Expenditur

RUMAH SUSUN DI KALIGAWE SEMARANG

“RUMAH SUSUN”, adalah bangunan gedung bertingkat yang dibangun dalam suatu lingkungan, yang terbagi dalam bagian-bagian yang distrukturkan secara fungsional dalam arah horizontal maupun vertikal dan merupakan satuan-satuan yang masing-masing dapat dimiliki dan digunakan secara terpisah, terutama untuk tempat hunian, yang dilengkapi dengan bagian-bersama, benda-bersama dan tanah-bersama. Kaligawe adalah salah satu kelurahan yang terdapat disemarang yang memilik permasalahan dalam bidang penyediaan lahan permukiman yang layak huni. Maka dari itu diperlukan suatu hunian berupa rumah susun yang mampu memenuhi kebutuhan masyarakat setempat secara kuantitatif, maupun menyediakan fasilitas dan sistem sanitasi yang memadai sehingga memudahkan para penghuni dalam beradaptasi dengan keadaan baru dalam menempati hunian vertikal. Bentuk dan penampilan bangunan rumah susun adalah dengan bentuk yang kontekstual terhadap lingkungannya.dengan tampilan rumah susun mengacu pada satuan unit modul. Dan fungsi bangunan mencerminkan arsitektur dengan iklim tropis

The adjuvant effect of Gantrez®AN nanoparticles on oral vaccination of pigs and mice with F4 fimbriae is strongly influenced by polymer degradation

We analysed the adjuvant effect of Gantrez nanoparticles NP on oral immunisation of pigs and mice with F4 fimbriae. The animals were vaccinated with F4, F4 encapsulated in Gantrez NP, called gF4 NP, or F4 + empty Gantrez NP, called F4 + gNP, and intragastrically infected with F4+ ETEC. The adjuvant effect of Gantrez®AN nanoparticles on oral vaccination of pigs and mice with F4 fimbriae is strongly influenced by polymer degradation

Pengaruh Komunikasi Interpersonal Keluarga dan Minat Belajar terhadap Hasil Belajar Ekonomi Siswa Kelas X SMKN 1 Solok Selatan.

ABSTACTThe impact of this research is to find out the interpersonal communication and economic interests of the students study at X SMKN 1 south solok. Technique of analysis data used by the linear regression analyses was of significant 44.70 with a double standard.The result showed that interpersonal communication: (1) the first grade student of SMKN 1 south solok is good. With average score 3.78 percent, and TCR 75,62. To interest the students of SMKN 1 south Solok is good whether it can be seen from the average score of 3, 74 and TCR 74,88 %. (2) the interpersonal communications variable influence significantly to study the student with a sig smaller than alpha 0,00 0.05 and variable interest to learn significant results are influence students with a sig smaller than alpha 0,00 < 0.05 (3) the coofisiensi determination is 0,712 that interpersonal communications the learning of the learned and the interests of the remaining 71,2 % by 28.8 % influence by these factors. As a result, its giving the maening for the influence that has significant communication international variable family and students attantion for a result of their economy study at SMKN 1 south Solok.Advised for the students to establish a better communication between a parent (mother father) and the son and also to increase their interest in learning and interest for the good and the study will be increased. Then for parents hope to take a little time to communicate to ask about students students learning activity. So, its can grow the students interest in studying, for teachers, to motivate and consider the students are interested in learning of the learned and students are getting better

Rationale and safety assessment of a novel intravaginal drug-delivery system with sustained DL-lactic acid release, intended for long-term protection of the vaginal microbiome

Bacterial vaginosis is a prevalent state of dysbiosis of the vaginal microbiota with wide-ranging impact on human reproductive health. Based on recent insights in community ecology of the vaginal microbiome, we hypothesize that sustained vaginal DL-lactic acid enrichment will enhance the recruitment of lactobacilli, while counteracting bacterial vaginosis-associated bacteria. We therefore aimed to develop an intravaginal device that would be easy to insert and remove, while providing sustained DL-lactic acid release into the vaginal lumen. The final prototype selected is a vaginal ring matrix system consisting of a mixture of ethylene vinyl acetate and methacrylic acid -methyl methacrylate copolymer loaded with 150 mg DL -lactic acid with an UD-lactic acid ratio of 1:1. Preclinical safety assessment was performed by use of the Slug Mucosal Irritation test, a non-vertebrate assay to evaluate vaginal mucosal irritation, which revealed no irritation. Clinical safety was evaluated in a phase I trial with six healthy nulliparous premenopausal volunteering women, with the investigational drug left in place for 7 days. Colposcopic monitoring according to the WHO/CONRAD guidelines for the evaluation of vaginal products, revealed no visible cervicovaginal mucosal changes. No adverse events related to the investigational product occurred. Total release from the intravaginal ring over 7 days was estimated through high performance liquid chromatography at 37.1 (standard deviation 0.9) mg DL -lactic acid. Semisolid lactic acid formulations have been studied to a limited extent in the past and typically consist of a large volume of excipients and very high doses of lactic acid, which is of major concern to mucosal safety. We have documented the feasability of enriching the vaginal environment with pure DL -lactic acid with a prototype intravaginal ring. Though the efficacy of this platform remains to be established possibly requiring further development, this approach may offer a novel avenue to modulate and protect the vaginal microbiota

Medication adherence among Turkish type-2 diabetics in Belgium: results from a qualitative study

Abstract title: Medication adherence among Turkish type-2 diabetics in Belgium: results from a qualitative study. Aim: Prevalence of diabetes in Belgium is 2 to 3 times higher among people from Turkish descent. Medication adherence, an essential element of the diabetic regimen, appears to be lower among nonwhite ethnic groups. This study identifies factors influencing medication adherence among Turkish type-2 diabetics living in Belgium. Methods: Since this topic hasn’t been studied before we conducted an explorative, qualitative study using semi-structured in-depth interviews with the aid of an interpreter. The topicslist was based on insights from the literature and conversations with Turkish diabetics and health care workers and was slightly adjusted after the first interviews. 21 Turkish type-2 diabetics living in Belgium were selected using theoretical sampling. Respondent’s most recent HbA1c-values were also collected. Interviews lasted between 2 and 5 hours, were audio-taped, fully transcribed and translated. Thematic analysis was conducted by the first two authors with different educational backgrounds (sociologist/pharmacist). The first phase was a detailed, thematic analysis of the individual cases, in the second phase an analysis across cases, distinguishing adherers from non-adherers, identified factors influencing medication adherence. NVivo 8 was used for managing, coding and analysing the qualitative data. Results: Factors influencing medication adherence among type-2 diabetics from Turkish descent include knowledge of and attitudes towards diabetes and antidiabetics, health and medication beliefs, social support from health care providers and family members, the nature of the patient-provider relationship, perceptions of health care worker’s expertise and social roles in daily life. A typology was constructed identifying different constellations of factors that distinguish adherers from non-adherers. Implications for clinical practice are discussed. Conclusion: This qualitative study identifies factors influencing medication adherence among type-2 Turkish diabetics living in Belgium and provides a typology, distinguishing adherers from non-adherers, that may guide clinical practice. Results from this qualitative study will be tested in a future, quantitative study